MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5 STAT ASSAY; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Model Number	E601
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 80225302 with an expiration date of 31-oct-2025.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys troponin t gen 5 stat assay results from the cobas 6000 e601 module.The initial result was 521 ng/l, which was questioned by the medical staff.A new sample was drawn from the patient and the troponin t result was 13.4 mg/l.The repeat result for the first sample using another analyzer was 12.83 ng/l the repeat result for the first sample using the original analyzer was 14.3 ng/l.The repeat results were believed to be correct.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.The field service engineer determined the event was due to sample quality.He checked the pinch tubings and ran precision on the troponin assay that was within specifications.Due to the limited information, the specific cause of the event could not be determined.The investigation did not identify a product problem.A general reagent problem was not present, because the qc prior to the event was within ranges.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• Common Device Name: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21129345
• Report Number: 1823260-2025-00102
• Device Sequence Number: 17849797
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: E601
• Device Catalogue Number: 08469865160
• Device Lot Number: 80225302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female